Medical device licence · 101524 · Class 3
INFINITY OCCIPITOCERVICAL UPPER THORACIC SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed July 27, 2018. It is in Health Canada’s list of active licences.
- Licence number
- 101524
- Licence holder
- Medtronic Sofamor Danek Usa, Inc.Memphis, TN, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- July 27, 2018
- Devices covered
- 39
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- DRILL BIT
- INFINITY NAVIGATED OCT SYSTEM 2.4MM NAV DRILL BIT
- INFINITY NAVIGATED OCT SYSTEM NAV DRILL BIT, NON
- INFINITY NAVIGATED OCT SYSTEM NAV DT GUIDE
- INFINITY NAVIGATED OCT SYSTEM NAV TAP
- INFINITY NAVIGATED OCT SYSTEM THREADED DRIVER NAV
- INFINITY OCCIPITOCERVICAL UPPER THORACIC SYSTEM 3.5MM PRE-CURVED OCCIPITAL COBALT CHROME ROD, 200MM
- INFINITY OCCIPITOCERVICAL UPPER THORACIC SYSTEM 3.5MM PRE-CURVED OCCIPITAL TITANIUM ROD, 200MM
- INFINITY OCCIPITOCERVICAL UPPER THORACIC SYSTEM 3.5MM PRE-CUT / BENT TITANIUM ROD, 25MM
- INFINITY OCCIPITOCERVICAL UPPER THORACIC SYSTEM ADJUSTABLE ROD SET SCREW
- INFINITY OCCIPITOCERVICAL UPPER THORACIC SYSTEM ANGLED OPEN LATERAL CONNECTOR
- INFINITY OCCIPITOCERVICAL UPPER THORACIC SYSTEM AXIAL DOMINO
- INFINITY OCCIPITOCERVICAL UPPER THORACIC SYSTEM CLOSED CONNECTOR FLAT SET SCREW
- INFINITY OCCIPITOCERVICAL UPPER THORACIC SYSTEM CLOSED LATERAL CONNECTOR
- INFINITY OCCIPITOCERVICAL UPPER THORACIC SYSTEM LAMINAR HOOK
- INFINITY OCCIPITOCERVICAL UPPER THORACIC SYSTEM MAS CROSSLINK
- INFINITY OCCIPITOCERVICAL UPPER THORACIC SYSTEM MAS EXTENSION CONNECTOR
- INFINITY OCCIPITOCERVICAL UPPER THORACIC SYSTEM MULTI AXIAL SCREW
- INFINITY OCCIPITOCERVICAL UPPER THORACIC SYSTEM OC ADJUSTABLE ROD
- INFINITY OCCIPITOCERVICAL UPPER THORACIC SYSTEM OC ADJUSTABLE ROD CCM+
- INFINITY OCCIPITOCERVICAL UPPER THORACIC SYSTEM OC BONE SCREW
- INFINITY OCCIPITOCERVICAL UPPER THORACIC SYSTEM OC BONE SCREW TAPERED
- INFINITY OCCIPITOCERVICAL UPPER THORACIC SYSTEM OC PLATE
- INFINITY OCCIPITOCERVICAL UPPER THORACIC SYSTEM OC SCREW CONNECTOR OFFSET
- INFINITY OCCIPITOCERVICAL UPPER THORACIC SYSTEM OC SCREW CONNECTOR REGULAR
- INFINITY OCCIPITOCERVICAL UPPER THORACIC SYSTEM OFFSET DOMINO
- INFINITY OCCIPITOCERVICAL UPPER THORACIC SYSTEM OFFSET OPEN/OPEN DOMINO
- INFINITY OCCIPITOCERVICAL UPPER THORACIC SYSTEM OPEN CONNECTOR CONED SET SCREW
- INFINITY OCCIPITOCERVICAL UPPER THORACIC SYSTEM OPEN LATERAL CONNECTOR
- INFINITY OCCIPITOCERVICAL UPPER THORACIC SYSTEM PARTIALLY THREADED MAS
- INFINITY OCCIPITOCERVICAL UPPER THORACIC SYSTEM PRE-CUT / BENT TITANIUM ROD
- INFINITY OCCIPITOCERVICAL UPPER THORACIC SYSTEM ROD 3.2MM TITANIUM
- INFINITY OCCIPITOCERVICAL UPPER THORACIC SYSTEM ROD CROSSLINK
- INFINITY OCCIPITOCERVICAL UPPER THORACIC SYSTEM SET SCREW M6
- OC DRILL BIT 3.2MM
- OC TAPERED DRILL BIT 3.2MM
- TAPERED COBALT CHROME ROD
- TAPERED ROD CHROMALOY PLUS
- TAPERED TITANIUM ROD
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.